Ankle FracturesNCT03607292
A Comparison Of Block Quality In Anterior And Posterior Approach To Sciatic Nerve Block
A study testing Anterior sciatic nerve block and Posterior sciatic nerve block in people with Ankle Fractures, run by Bagcilar Training and Research Hospital.
Trial summary
Co-administration of the sciatic nerve block and femoral nerve block may provide anesthesia and analgesia in patients undergoing lower extremity surgery. Several approaches to sciatic nerve block have been described. The anterior and posterior approaches are two of the approaches used to make the sciatic nerve block. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Ankle Fractures
- What is being tested?
- Anterior sciatic nerve block and Posterior sciatic nerve block
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- No sites listed yet
- Study dates
- 18 Mar 2013to 20 Dec 2014
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients who were between the ages of 18 to 65 and were going to be operated due to lateral and/or medial malleolus fracture.
Who cannot join
- -
About this study
Co-administration of the sciatic nerve block and femoral nerve block may provide anesthesia and analgesia in patients undergoing lower extremity surgery. Several approaches to sciatic nerve block have been described. The anterior and posterior approaches are two of the approaches used to make the sciatic nerve block. In our study, n = 20 patients for Group A and n = 25 patients for Group P were included. Then, sciatic nerve block and femoral nerve block were performed to each patient by using anterior or posterior approach randomly. After the block is performed, the sensory and motor block start and end times, the first intraoperative fentanyl requirement time and total amount of fentanyl required, the first Diclofenac sodium requirement time, and the total amount of diclofenac sodium that patients required were determined. As the groups were compared to each other; the time to start sensory block was statistically significantly lower, the first fentanyl requirement time was statistically significantly earlier and the total amount of fentanyl required was statistically significantly lower in Group P. Patient satisfaction, anesthesia quality and surgical quality were statistically significantly higher in Group P. In this study, the investigators concluded that if a patient does not have pain secondary to fracture, posterior approach to sciatic nerve block can be performed, whereas, if a patient has pain secondary to fracture, anterior approach to sciatic nerve block can be performed in order to avoid repositioning.
Read the detailed description
Forty five patients were enrolled to the study. These patients were classified in the American Society of Anesthesiologists (ASA) I-II group. The written informed consent of each patient was obtained.
The study was randomized, single blinded and prospectively planned. Randomization was done according to the randomization table prepared by the computer. A single blinded anesthesiologist performed posterior or anterior sciatic nerve block and femoral block and left the operating room after the patient was corrected after the nerve block was completed and another anesthesiologist followed the patient without knowing what approach was used. Before initiating the study, the required number of participants was determined according to the results of a pilot study which was performed by enrolling 10 patients in each group.
The time of sciatic nerve sensory block onset ± Standard Deviation (SD) was calculated as 8,88 ± 4,87 minutes for Group A (anterior approach to sciatic nerve block + femoral nerve block) and 4.70 ± 2.05 minutes for Group P (posterior approach to sciatic nerve block + femoral nerve block). The sample size was calculated on websites named www.power and www.sample size.com/Calculators/Compare-2-means/2-Sample-Equality. The sample size was calculated as 25 (n = 25) for Group A and 7 (n = 7) for Group P, while α = 5% with 85% power. Whereas, 20 patients were enrolled for Group P because small n should be greater than half of large n for reliability.
The patient's age, gender, height, weight, other existing diseases, drug use, smoking history, anesthetic method applied, operation time, tourniquet time, ASA classification, intraoperative first fentanyl requirement time and total fentanyl amount during the operation, measurements of systolic, diastolic and mean blood pressures, heart rate and peripheral oxygen saturation values before and after the block, motor and sensory block start and end times after sciatic and femoral block were performed, first Diclofenac sodium time and total Diclofenac sodium amount administered in 24 hours, visual analogue scale (VAS) values, patient satisfaction, anesthetic quality from the point of anesthesiologist, and surgical quality from the point of surgeon were recorded.
Patients who were informed about VAS one day before and not administered premedication were taken to the regional block room and routine electrocardiogram, noninvasive arterial blood pressure and peripheral pulse oximeter monitoring were performed. Baseline values of blood pressure, heart rate and peripheral oxygen saturation were recorded before the block was performed. During the operation these values were recorded every 5 minutes.
First of all, the sciatic nerve block with anterior approach was performed in the group A. The block was performed by the needle named Stimuplex® A (21G 0.80-150), which was at 30 ° and isolated in conjunction with a block nerve stimulator (Stimuplex HNS nerve stimulator BRAUN, Germany) and ultrasonography (USG) (Diagnostic ultrasound system, Model SDU 450 XL Class-1 type B Shimadzu Corporation, Japan) mm). A total of 40 ml of a local anesthetic solution composed of 30 ml of 0.5% isobaric bupivacaine and 10 mL of 2% lidocaine was prepared.
In both the anterior and posterior approach to sciatic nerve block and the femoral nerve block, nerve stimulation was done with a frequency of 2 Hz and with 1 Milliampere (mA) current, and the stimulus intensity was gradually reduced to 0.4 mA as long as the as response was obtained. Femoral nerve block: The nerve was visualized in direct USG coincidence and the needle was oriented to the nerve. After the contraction of vastus medialis, vastus intermedius, and vastus lateralis muscles were visualized, local anesthetic mixture of 20 ml was injected and dissemination of the local anesthetic solution was imaged by USG (Linear probe).
Anterior sciatic nerve block: Technically, a straight line along the femoral catheter was drawn between the anterior superior iliac spine and the finger palpating the pubic bone, the index finger was placed over the femoral artery pulse, a line was drawn perpendicular to the femoral fold. Over the pulse of the femoral artery, a point 4-5 cm lateral to this line was marked and this point was identified as the needle entry point. The sciatic nerve was imaged by USG (Convex probe) along the needle route and the needle was advanced to the nerve. When the plantar flexion, dorsal flexion and eversion of the foot were observed, 20 mL of local anesthetic mixture was given and local anesthetic spread was imaged by USG simultaneously.
Posterior sciatic nerve block: The patient was positioned laterally, with the limb to be blocked uppermost. The lower leg was straight extended and the upper extremity was bent 90 ° from the knee and was directed forward on the lower straight extended extremity. The patient's greater trochanter and posterior superior iliac spine were palpated and joined with a line, then the middle point of this line was found and a line was drawn 4 cm above the first line perpendicular to the caudal line. The end point of the 2nd line was taken as the entry point of the needle. The USG probe was placed between the greater trochanter and the coccyx at the entry point of the needle and the needle was advanced by imaging the nerve. When the plantar flexion, dorsal flexion, and eversion of the foot were observed, 20 mL of local anesthetic mixture was given and local anesthetic spread was imaged by USG simultaneously.
After the blocks were completed, the motor block was assessed by monitoring the movement of the ankle joint and knee, and sensory block was assessed with a cold application every minute, and the block start times were recorded. When the patient was not receiving any stimulation with cold application on sciatic and femoral stimulation areas, it was recorded as the start time of the full femoral-sciatic sensory block. When the knee joint could not be moved at all, it was recorded as the start time of the full femoral motor block.
When the ankle joint was unable to move, it was recorded as the start time of the full sciatic motor block. After the block was fully achieved, the tourniquet was applied to the extremity to be operated and was inflated. Patients underwent surgery 30 minutes after the block was provided. After the surgical procedure started, 1 μg kg-1 fentanyl was injected intramuscularly when the VAS values of the patients were greater than 4. The patient's first fentanyl requirement time and the total amount of fentanyl administered during the operation were recorded.
When the arterial blood pressures of a patient fell below 80% of pre-block values, 5 mg ephedrine was administered intramuscularly. Intravenous administration of 0.5 mg atropine was planned when the heart rate dropped below 50 beats min-1. When the patients had nausea and vomiting, 4 mg of ondansetron (Zofer, Adeka, Turkey) was administered intramuscularly.
After the operation was completed, the patients were taken to the postoperative care unit. Patients were followed in the postoperative care unit until the block was completely terminated. Patients were sent to the clinic after the block was terminated. The time of first diclofenac sodium required by the patients and the amount of diclofenac sodium administered within 24 hours of the post-operative period were recorded. The first postoperative diclofenac sodium dose was administered when a patient had VAS values of 4 or more.
All data were evaluated using the SPSS 11.5 for Windows package program. The normality distribution of the data was assessed by the Kolmogorov-Smirnov test. In the complementary statistics of the data, the mean ± standard deviation values for the parametric tests and the median (minimum-maximum) for the nonparametric tests were used. Categorical data were given as %n. Independent-Samples T Test was used for binary comparison of the data of the groups, chi-square test was used for comparing the categorical data of the groups. In order to make comparison in all of the statistical data, p <0.05 was considered statistically significant.
- Conditions
- Ankle Fractures
- Being tested
- Anterior sciatic nerve block, Posterior sciatic nerve block
- Keywords
- Sciatic Nerve Blocks, Ankle surgery
- Medical subject headings
- Ankle Fractures
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Anterior sciatic nerve blockProcedure or surgery
A straight line along the femoral catheter was drawn between the anterior superior iliac spine and the finger palpating the pubic bone, the index finger was placed over the femoral artery pulse, a line was drawn perpendicular to the femoral fold. Over the pulse of the femoral artery, a point 4-5 cm lateral. The sciatic nerve was imaged by USG along the needle route and the needle was advanced to the nerve.
Posterior sciatic nerve blockProcedure or surgery
Patient was positioned laterally, with the limb to be blocked uppermost. The lower leg was straight extended and the upper extremity was bent 90° from the knee and was directed forward on the lower straight extended extremity. The patient's greater trochanter and posterior superior iliac spine were palpated and joined with a line, and a line was drawn 4 cm above the first line perpendicular to the caudal line. The USG probe was placed between the greater trochanter and the coccyx at the entry point of the needle and the needle was advanced by imaging the nerve.
| Study group | Role | What they receive |
|---|---|---|
| Group A | Experimental | Anterior sciatic nerve block Receives: Procedure: Anterior sciatic nerve block |
| Group P | Experimental | Posterior sciatic nerve block Receives: Procedure: Posterior sciatic nerve block |
What is being measured
The primary outcome is the main question the study is designed to answer.
Comparison of sensorial block start time after sciatic nerve block performed with anterior and posterior approaches.
Sensory block was assessed with a cold application every minute, and the block start time was recorded. When the patient was not receiving any stimulation with cold application on sciatic stimulation area, it was recorded as the start time of the full sciatic sensory block.
Measured: up to 20 minutes.
Secondary outcomes (12)
Comparison of sensorial block end time after sciatic nerve block performed with anterior and posterior approaches.
Sensory block was assessed with a cold application every minute, and the block end time was recorded. When the patient received any stimulation with cold application on sciatic stimulation area, it was recorded as the end time of the full sciatic sensory block.
Measured: up to 300 minutes.
Comparison of sensorial block start time after femoral nerve block performed with anterior and posterior approaches.
Sensory block was assessed with a cold application every minute, and the block start time was recorded. When the patient was not receiving any stimulation with cold application on femoral stimulation area, it was recorded as the start time of the full femoral sensory block.
Measured: up to 20 minutes.
Comparison of sensorial block end time after femoral nerve block performed with anterior and posterior approaches.
Sensory block was assessed with a cold application every minute, and the block end time was recorded. When the patient received any stimulation with cold application on femoral stimulation area, it was recorded as the end time of the full femoral sensory block.
Measured: up to 160 minutes.
Comparison of patient satisfaction
Patient satisfaction:0: failed,1: weak, 2: moderate, 3: good, 4: excellent
Measured: After surgery up to 24 hours.
Comparison of anesthesia quality in groups
Anesthesia quality assesment by Anesthesiologist; 1: Failed; general anesthesia was required, 2: Moderate, complainant, complementary analgesic was needed, 3: Good, little complainant, no need for complementary analgesia, 4: Excellent, patients do not complain
Measured: After surgery up to 24 hours.
Comparison of surgical quality in groups
surgical quality assesment by Surgeon; 1: Failed; general anesthesia was required, 2: Moderate, complainant, complementary analgesic was needed, 3: Good, little complainant, no need for complementary analgesia, 4: Excellent, patients do not complain
Measured: After surgery up to 24 hours.
Comparison of intra-operatively administered total fentanyl amount and total diclofenac sodium amount in the postoperative first 24-hour periods in the group.
After the surgical procedure started, 1 μg kg-1 fentanyl was injected intramuscularly when the VAS values of the patients were greater than 4. The patient's total amount of fentanyl administered during the operation was recorded. After the operation was completed, the amount of diclofenac sodium administered within 24 hours of the post-operative period were recorded.
Measured: within 24 hours of the post-operative period
Comparison of intra-operatively administered first fentanyl requirement time and first diclofenac sodium requirement times in the postoperative first 24-hour periods in the groups.
After the surgical procedure started, 1 μg kg-1 fentanyl was injected intramuscularly when the VAS values of the patients were greater than 4. The patient's first fentanyl requirement time during the operation were recorded. After the operation was completed, the time of first diclofenac sodium required by the patients within 24 hours of the post-operative period was recorded. The first postoperative diclofenac sodium dose was administered when a patient had VAS values of 4 or more.
Measured: within 24 hours of the post-operative period
Comparison of motor block start time after sciatic nerve block performed with anterior and posterior approaches.
When the ankle joint was unable to move, it was recorded as the start time of the full sciatic motor block.
Measured: every minute up to 20 minutes.
Comparison of motor block end time after sciatic nerve block performed with anterior and posterior approaches.
When the ankle joint was able to move, it was recorded as the end time of the full sciatic motor block.
Measured: every minute up to 160 minutes.
Comparison of motor block start time after femoral nerve block performed with anterior and posterior approaches.
When the knee joint could not be moved at all, it was recorded as the start time of the full femoral motor block.
Measured: every minute up to 20 minutes.
Comparison of motor block end time after femoral nerve block performed with anterior and posterior approaches.
When the knee joint could be moved at all, it was recorded as the end time of the full femoral motor block.
Measured: every minute up to 110 minutes.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jul 2018
- Study start18 Mar 2013
- Primary completion18 Mar 2014
- Study completion20 Dec 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ankle FracturesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomize, single blind, prospective
- Masking
- None (open label)
- Enrolment
- 45 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bagcilar Training and Research Hospital
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Abdulkadir Yektas, Bagcilar Training and Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03607292
- Sponsor's protocol ID
- Sciatic Nerve Block
- Status last verified
- Jul 2018
- First submitted
- 11 Jun 2018
- Last updated
- 31 Jul 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Jul 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Comparison Of Block Quality In Anterior And Posterior Approach To Sciatic Nerve Block
- ClinicalTrials.gov ID
- NCT03607292
- Acronym / sponsor ID
- Sciatic Nerve Block
- Conditions
- Ankle Fractures
- Keywords
- Sciatic Nerve Blocks, Ankle surgery
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 45 participants (actual)
- Lead sponsor
- Bagcilar Training and Research HospitalOther government
- Study start
- 18 Mar 2013 (actual)
- Primary completion
- 18 Mar 2014 (actual)
- Study completion
- 20 Dec 2014 (actual)
- First posted
- 31 Jul 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Co-administration of the sciatic nerve block and femoral nerve block may provide anesthesia and analgesia in patients undergoing lower extremity surgery. Several approaches to sciatic nerve block have been described. The anterior and posterior approaches are two of the approaches used to make the sciatic nerve block. In our study, n = 20 patients for Group A and n = 25 patients for Group P were included. Then, sciatic nerve block and femoral nerve block were performed to each patient by using anterior or posterior approach randomly. After the block is performed, the sensory and motor block start and end times, the first intraoperative fentanyl requirement time and total amount of fentanyl required, the first Diclofenac sodium requirement time, and the total amount of diclofenac sodium that patients required were determined. As the groups were compared to each other; the time to start sensory block was statistically significantly lower, the first fentanyl requirement time was statistically significantly earlier and the total amount of fentanyl required was statistically significantly lower in Group P. Patient satisfaction, anesthesia quality and surgical quality were statistically significantly higher in Group P. In this study, the investigators concluded that if a patient does not have pain secondary to fracture, posterior approach to sciatic nerve block can be performed, whereas, if a patient has pain secondary to fracture, anterior approach to sciatic nerve block can be performed in order to avoid repositioning.
Detailed description
Forty five patients were enrolled to the study. These patients were classified in the American Society of Anesthesiologists (ASA) I-II group. The written informed consent of each patient was obtained.
The study was randomized, single blinded and prospectively planned. Randomization was done according to the randomization table prepared by the computer. A single blinded anesthesiologist performed posterior or anterior sciatic nerve block and femoral block and left the operating room after the patient was corrected after the nerve block was completed and another anesthesiologist followed the patient without knowing what approach was used. Before initiating the study, the required number of participants was determined according to the results of a pilot study which was performed by enrolling 10 patients in each group.
The time of sciatic nerve sensory block onset ± Standard Deviation (SD) was calculated as 8,88 ± 4,87 minutes for Group A (anterior approach to sciatic nerve block + femoral nerve block) and 4.70 ± 2.05 minutes for Group P (posterior approach to sciatic nerve block + femoral nerve block). The sample size was calculated on websites named www.power and www.sample size.com/Calculators/Compare-2-means/2-Sample-Equality. The sample size was calculated as 25 (n = 25) for Group A and 7 (n = 7) for Group P, while α = 5% with 85% power. Whereas, 20 patients were enrolled for Group P because small n should be greater than half of large n for reliability.
The patient's age, gender, height, weight, other existing diseases, drug use, smoking history, anesthetic method applied, operation time, tourniquet time, ASA classification, intraoperative first fentanyl requirement time and total fentanyl amount during the operation, measurements of systolic, diastolic and mean blood pressures, heart rate and peripheral oxygen saturation values before and after the block, motor and sensory block start and end times after sciatic and femoral block were performed, first Diclofenac sodium time and total Diclofenac sodium amount administered in 24 hours, visual analogue scale (VAS) values, patient satisfaction, anesthetic quality from the point of anesthesiologist, and surgical quality from the point of surgeon were recorded.
Patients who were informed about VAS one day before and not administered premedication were taken to the regional block room and routine electrocardiogram, noninvasive arterial blood pressure and peripheral pulse oximeter monitoring were performed. Baseline values of blood pressure, heart rate and peripheral oxygen saturation were recorded before the block was performed. During the operation these values were recorded every 5 minutes.
First of all, the sciatic nerve block with anterior approach was performed in the group A. The block was performed by the needle named Stimuplex® A (21G 0.80-150), which was at 30 ° and isolated in conjunction with a block nerve stimulator (Stimuplex HNS nerve stimulator BRAUN, Germany) and ultrasonography (USG) (Diagnostic ultrasound system, Model SDU 450 XL Class-1 type B Shimadzu Corporation, Japan) mm). A total of 40 ml of a local anesthetic solution composed of 30 ml of 0.5% isobaric bupivacaine and 10 mL of 2% lidocaine was prepared.
In both the anterior and posterior approach to sciatic nerve block and the femoral nerve block, nerve stimulation was done with a frequency of 2 Hz and with 1 Milliampere (mA) current, and the stimulus intensity was gradually reduced to 0.4 mA as long as the as response was obtained. Femoral nerve block: The nerve was visualized in direct USG coincidence and the needle was oriented to the nerve. After the contraction of vastus medialis, vastus intermedius, and vastus lateralis muscles were visualized, local anesthetic mixture of 20 ml was injected and dissemination of the local anesthetic solution was imaged by USG (Linear probe).
Anterior sciatic nerve block: Technically, a straight line along the femoral catheter was drawn between the anterior superior iliac spine and the finger palpating the pubic bone, the index finger was placed over the femoral artery pulse, a line was drawn perpendicular to the femoral fold. Over the pulse of the femoral artery, a point 4-5 cm lateral to this line was marked and this point was identified as the needle entry point. The sciatic nerve was imaged by USG (Convex probe) along the needle route and the needle was advanced to the nerve. When the plantar flexion, dorsal flexion and eversion of the foot were observed, 20 mL of local anesthetic mixture was given and local anesthetic spread was imaged by USG simultaneously.
Posterior sciatic nerve block: The patient was positioned laterally, with the limb to be blocked uppermost. The lower leg was straight extended and the upper extremity was bent 90 ° from the knee and was directed forward on the lower straight extended extremity. The patient's greater trochanter and posterior superior iliac spine were palpated and joined with a line, then the middle point of this line was found and a line was drawn 4 cm above the first line perpendicular to the caudal line. The end point of the 2nd line was taken as the entry point of the needle. The USG probe was placed between the greater trochanter and the coccyx at the entry point of the needle and the needle was advanced by imaging the nerve. When the plantar flexion, dorsal flexion, and eversion of the foot were observed, 20 mL of local anesthetic mixture was given and local anesthetic spread was imaged by USG simultaneously.
After the blocks were completed, the motor block was assessed by monitoring the movement of the ankle joint and knee, and sensory block was assessed with a cold application every minute, and the block start times were recorded. When the patient was not receiving any stimulation with cold application on sciatic and femoral stimulation areas, it was recorded as the start time of the full femoral-sciatic sensory block. When the knee joint could not be moved at all, it was recorded as the start time of the full femoral motor block.
When the ankle joint was unable to move, it was recorded as the start time of the full sciatic motor block. After the block was fully achieved, the tourniquet was applied to the extremity to be operated and was inflated. Patients underwent surgery 30 minutes after the block was provided. After the surgical procedure started, 1 μg kg-1 fentanyl was injected intramuscularly when the VAS values of the patients were greater than 4. The patient's first fentanyl requirement time and the total amount of fentanyl administered during the operation were recorded.
When the arterial blood pressures of a patient fell below 80% of pre-block values, 5 mg ephedrine was administered intramuscularly. Intravenous administration of 0.5 mg atropine was planned when the heart rate dropped below 50 beats min-1. When the patients had nausea and vomiting, 4 mg of ondansetron (Zofer, Adeka, Turkey) was administered intramuscularly.
After the operation was completed, the patients were taken to the postoperative care unit. Patients were followed in the postoperative care unit until the block was completely terminated. Patients were sent to the clinic after the block was terminated. The time of first diclofenac sodium required by the patients and the amount of diclofenac sodium administered within 24 hours of the post-operative period were recorded. The first postoperative diclofenac sodium dose was administered when a patient had VAS values of 4 or more.
All data were evaluated using the SPSS 11.5 for Windows package program. The normality distribution of the data was assessed by the Kolmogorov-Smirnov test. In the complementary statistics of the data, the mean ± standard deviation values for the parametric tests and the median (minimum-maximum) for the nonparametric tests were used. Categorical data were given as %n. Independent-Samples T Test was used for binary comparison of the data of the groups, chi-square test was used for comparing the categorical data of the groups. In order to make comparison in all of the statistical data, p <0.05 was considered statistically significant.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Randomize, single blind, prospective
| Arm | Type | Receives |
|---|---|---|
| Group A | Experimental | Procedure: Anterior sciatic nerve blockAnterior sciatic nerve block |
| Group P | Experimental | Procedure: Posterior sciatic nerve blockPosterior sciatic nerve block |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients who were between the ages of 18 to 65 and were going to be operated due to lateral and/or medial malleolus fracture.
Key exclusion criteria (1 listed)
- -
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Anterior sciatic nerve blockA straight line along the femoral catheter was drawn between the anterior superior iliac spine and the finger palpating the pubic bone, the index finger was placed over the femoral artery pulse, a line was drawn perpendicular to the femoral fold. Over the pulse of the femoral artery, a point 4-5 cm lateral. The sciatic nerve was imaged by USG along the needle route and the needle was advanced to the nerve. | Procedure or surgery | Group A |
| Posterior sciatic nerve blockPatient was positioned laterally, with the limb to be blocked uppermost. The lower leg was straight extended and the upper extremity was bent 90° from the knee and was directed forward on the lower straight extended extremity. The patient's greater trochanter and posterior superior iliac spine were palpated and joined with a line, and a line was drawn 4 cm above the first line perpendicular to the caudal line. The USG probe was placed between the greater trochanter and the coccyx at the entry point of the needle and the needle was advanced by imaging the nerve. | Procedure or surgery | Group P |
Primary outcome
Comparison of sensorial block start time after sciatic nerve block performed with anterior and posterior approaches.
Time frame: up to 20 minutes.
Sensory block was assessed with a cold application every minute, and the block start time was recorded. When the patient was not receiving any stimulation with cold application on sciatic stimulation area, it was recorded as the start time of the full sciatic sensory block.
12 secondary outcomes
Comparison of sensorial block end time after sciatic nerve block performed with anterior and posterior approaches.
Time frame: up to 300 minutes.
Comparison of sensorial block start time after femoral nerve block performed with anterior and posterior approaches.
Time frame: up to 20 minutes.
Comparison of sensorial block end time after femoral nerve block performed with anterior and posterior approaches.
Time frame: up to 160 minutes.
Comparison of patient satisfaction
Time frame: After surgery up to 24 hours.
Comparison of anesthesia quality in groups
Time frame: After surgery up to 24 hours.
Comparison of surgical quality in groups
Time frame: After surgery up to 24 hours.
Comparison of intra-operatively administered total fentanyl amount and total diclofenac sodium amount in the postoperative first 24-hour periods in the group.
Time frame: within 24 hours of the post-operative period
Comparison of intra-operatively administered first fentanyl requirement time and first diclofenac sodium requirement times in the postoperative first 24-hour periods in the groups.
Time frame: within 24 hours of the post-operative period
Comparison of motor block start time after sciatic nerve block performed with anterior and posterior approaches.
Time frame: every minute up to 20 minutes.
Comparison of motor block end time after sciatic nerve block performed with anterior and posterior approaches.
Time frame: every minute up to 160 minutes.
Comparison of motor block start time after femoral nerve block performed with anterior and posterior approaches.
Time frame: every minute up to 20 minutes.
Comparison of motor block end time after femoral nerve block performed with anterior and posterior approaches.
Time frame: every minute up to 110 minutes.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Jul 2018.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Anterior sciatic nerve block and Posterior sciatic nerve block in people with Ankle Fractures, run by Bagcilar Training and Research Hospital.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 31 Jul 2018. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Comparison of sensorial block start time after sciatic nerve block performed with anterior and posterior approaches. (time frame: up to 20 minutes.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Jul 2018.